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Trial record 1 of 2 for:    Organicell
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Organicell Flow for Patients With COVID-19

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ClinicalTrials.gov Identifier: NCT04384445
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Organicell Regenerative Medicine

Brief Summary:
The purpose of this research study is to evaluate the safety and potential efficacy of Intravenous Infusion of Organicell Flow for treatment of moderate to severe Acute Respiratory Syndrome (SARS) related to COVID-19 infection vs Placebo.

Condition or disease Intervention/treatment Phase
Corona Virus Infection COVID-19 SARS Acute Respiratory Distress Syndrome Biological: Organicell Flow Other: Placebo Phase 1 Phase 2

Detailed Description:

A human coronavirus (HCoV-19) has caused the novel coronavirus disease (COVID-19) outbreak worldwide. Common symptoms of COVID-19 include fever, cough, and shortness of breath. The majority of cases result in mild symptoms, but some can progress into pneumonia and multi-organ failure. According to the severity it is divided into mild, normal, severe and critically ill, which is associated with ICU admission and mortality. At present, the standard treatment of COVD-19 patients is oxygen therapy, mechanical ventilation, and medications to maintain blood pressure. As of today, no specific antiviral therapy is available for patients with COVID-19. Immune activation in some patients, and the appearance of cytokine storm syndrome (CSS) is one of the important causes of severe damage to lungs and other organs, which may lead to death. There is an urgent need to develop new interventions to suppress the excessive immune response in a timely manner during the course of disease, protect alveolar function, and reduce lung and systemic organ damage.

Organicell Flow is an acellular, minimally manipulated product, derived from human amniotic fluid (HAF). This product contains over 300 growth factors, cytokines, and chemokines as well as other extracellular vesicles/nanoparticles derived from amniotic stem and epithelial cells. The product contains a mean concentration of 5.24x10^11 particles/mL with a mean mode size of 125.2nm. Surface marker analysis confirmed the presence of exosome associated proteins CD63, CD81, and CD9 in addition to high expression of CD133. The completed sequencing revealed 102 commonly expressed miRNA (with a 100-copy expression minimum). Bioinformatics analysis linked 63 miRNAs to 1216 RNA targets. Major players in the proinflammatory cytokine cascade found to be targeted by miRNA were discovered in Organicell's product include TNF, IL-6, and IL-8. Additionally, a broader array of pro-inflammatory cytokines is also targeted by the collection of miRNA such as FGF2, IFNB1, IGF1, IL36a, IL37, TGF-B2, VEGFA, CCL8, and CXCL12. It has been suggested in published research that inhibition or suppression of this pro-inflammatory cytokine cascade may reduce the severity of symptoms associated with elevated immune response. Furthermore, the miRNA was found to target 148 genes associated with immune response.

The property of Organicell Flow demonstrates the therapeutic potential as a suppressor of cytokine activation for the reduction of COVID-19 infection severity. This study aims to investigate safety and potential efficacy of HAF derived acellular product in subjects suffering form COVID-19 infection with severe acute respiratory syndrome (SARS).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The trial has two groups, each with 10 subjects (n=20). All eligible study subjects will be randomized, double blinded, to either the treatment group or placebo group.
Masking: Double (Participant, Investigator)
Masking Description: Double blind: neither subjects nor the investigators who are assessing the patient are award of the treatment assignment until the end of the study.
Primary Purpose: Treatment
Official Title: A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Organicell Flow for the Treatment of Moderate to SARS Related to COVID-19 Infection vs Placebo
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Organicell Flow Plus Standard Care
Participants in this group will receive standard of care plus Organicell Flow on day 0, day 4 and day 8.
Biological: Organicell Flow
Biological: Organicell Flow. Organicell Flow will be administered intravenously with 1ml, containing 2-5 x 10^11 particles/mL in addition to the Standard Care. The Organicell Flow dose will be diluted in 100 mL of sterile saline at subject's bedside.

Placebo Comparator: Placebo Plus Standard Care
Participants in this group will receive standard of care plus placebo (Saline) on day 0, day 4 and day 8.
Other: Placebo
Other: Placebo Placebo (saline) will be administered intravenously with 1ml in addition to the Standard Care. The Placebo dose will be diluted in 100 mL of sterile saline at subject's bedside.




Primary Outcome Measures :
  1. Incidence of any infusion associated adverse events [ Time Frame: 60 Days ]
    Safety will be defined by the incidence of any infusion associated adverse events as assessed by treating physician

  2. Incidence of Severe Adverse Events [ Time Frame: 60 Days ]
    Safety will be defined by the incidence of severe adverse events as assessed by treating physician


Secondary Outcome Measures :
  1. All Cause Mortality [ Time Frame: 60 Days ]
    Measured at day 60 or at hospital discharge, whichever comes first.

  2. Survival Rate [ Time Frame: 60 Days ]
    Number of participants that are alive at 60 days post first infusion follow up

  3. Cytokine Levels [ Time Frame: Day 0, Day 4, Day 8, Day14, Day 21, Day 28 ]
    Measure IL-6, IL-2, TNF-alpha from serum of blood samples

  4. D-dimer Levels [ Time Frame: Day 0, Day 4, Day 8, Day14, Day 21, Day 28 ]
    D-dimer from serum of blood samples methodology using blood samples or nose / throat swab

  5. C-reactive protein Levels [ Time Frame: Day 0, Day 4, Day 8, Day14, Day 21, Day 28 ]
    CRP from serum of blood samples

  6. Quantification of the COVID-19 [ Time Frame: Day 0, Day 4, Day 8 ]
    Viral load by real time RT methodology using blood samples or nose / throat swab

  7. Improved Organ Failure [ Time Frame: Day 30 ]
    Improved organ failure within 30 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs using Sequential Organ Failure Assessment (SOFA) score.

  8. Chest Imaging Changes [ Time Frame: Day o, Day 30 ]

    Chest imaging changes for 30 days compare to placebo: 1) Ground-glass opacity,

    - 2) Local patchy shadowing, 3) Bilateral patchy shadowing, and 4) Interstitial abnormalities.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide written informed consent
  2. Subjects age > 18 years at the time of signing the Informed Consent Form.
  3. Male or Female
  4. Must have a clinical diagnosis of COVID-19, with at least one of clinical symptoms (e.g., fever ≥38°C, fatigue, cough) and a positive result by the reverse- transcription polymerase chain reaction (RT-PCR) testing or equivalent.
  5. Individuals with moderately to severe COVID-19 symptoms.

    Moderate ARDS according to Berlin Criteria:

    Symptoms include: abnormal chest imaging or any degree of hypoxia requiring supplemental oxygen. Bilateral opacities—not fully explained by effusions, lobar/lung collapse, or nodules. Oxygenation: 100 mm Hg < PaO2/FIO2 </= 200 mm Hg with PEEP >/=5 cm H2O

    Severe ARDS according to Berlin Criteria:

    Symptoms include: abnormal chest imaging or any degree of hypoxia requiring supplemental oxygen. Bilateral opacities—not fully explained by effusions, lobar/lung collapse, or nodules. Oxygenation: PaO2/FIO2 </= 100 mm Hg with PEEP >/= 5 cm H2O

  6. Hospitalized and symptomatic (cough, fevers, SOB, or sputum production)
  7. Adequate venous access
  8. Ability to provide informed consent or an authorized representative can sign the informed consent
  9. For female patients only, willingness to use FDA- recommended birth control (http://www.fda.gov/downloads/ForConsumers/ByAu dience/ForWomen/FreePublications/UCM356451.pdf ) until 6 months post treatment.
  10. Must agree to comply with all study requirements and be willing to complete all study visits
  11. Willingness of study participant to accept this treatment arm, and signed informed consent; Need in- patient admission.

Exclusion Criteria:

  1. Intubated or on a ventilator.
  2. Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood or urine pregnancy test at screening and within 36 hours prior to infusion.
  3. Inability to perform any of the assessments required for endpoint analysis.
  4. Active listing (or expected future listing) for transplant of any organ.
  5. Be a solid organ transplant recipient. This does not include prior cell-based therapy (>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting. Have a history of organ or cell transplant rejection.
  6. History of drug abuse (illegal "street" drugs except marijuana, or prescription medications not being used appropriately for a pre-existing medical condition) or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months
  7. Be serum positive for HIV, hepatitis BsAg or hepatitis C.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384445


Contacts
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Contact: Maria Ines Mitrani, MD, PhD 1-888-963-7881 clinicaltrials@organicell.com

Locations
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United States, Florida
Landmark Hospital
Naples, Florida, United States, 34109
Contact: George Shapiro, MD         
United States, Georgia
Landmark Hospital
Athens, Georgia, United States, 30606
Contact: Marie Saylor, RN, MSN    706-425-1500    clinicaltrials@organicell.com   
Sponsors and Collaborators
Organicell Regenerative Medicine
Investigators
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Principal Investigator: George C Shapiro, MD, FACC Chief Medical Officer at Organicell Regenerative Medicine, Inc
Principal Investigator: Maria Ines Mitrani, MD, PhD Chief Science Officer at Organicell Regenerative Medicine, Inc
Principal Investigator: William Kapp, MD, FAAOS Co-Investigator
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Responsible Party: Organicell Regenerative Medicine
ClinicalTrials.gov Identifier: NCT04384445    
Other Study ID Numbers: 19881
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Organicell Regenerative Medicine:
Human Amniotic Fluid
Exosomes
Human
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Virus Diseases
Lung Injury
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections